偏差CAPA有效性中的几个考量点
QA

   在偏差调查过程中,CAPA 制定的有效性尤为重要,首先需要符合SMART原则,另外,一个有效的CAPA可以通过以下几个考量点进行检查,可以作为一个checklist 作为辅助工具:


  1. Does the corrective/preventive actions address the root cause/contributing factor?
  2. Are the corrective/preventive actions foucus on prevention or proof? If not why not?
  3. Are the corrective/preventive actions sustainable?
  4. Challenge the corrective actions to ensure that they will prevent re-occurrence?
  5. Can a unfamiliar reader understand and implement the corrective/preventive action?
  6. Is this action going to have a negative impact on subsequent processes and related systems?
  7. If the corrective/preventive action will take time to implement, is there an interim action to prevent re-occurrence?
  8. Have Process owners / end users been consulted?
  9. What is the plan to inform process owners / end users of new actions?